Background
Following a request from the Belarusian, Russian and Ukrainian authorities, the European Commission established the Chernobyl Regional Programme as a part of the TACIS 1993 Nuclear Safety Programme. The programme was intended to assist those countries in dealing with the consequences of the Chernobyl accident.
The programme began with a rapid exercise to assess the needs of the three countries, identify actions already undertaken and define the key priorities for funding by the EC and other donors.
It was initially anticipated that first efforts would concentrate on actions to limit the consequences of soil contamination, but, subject to initial assessment, other actions dealing with the social and economic problems resulting from the Chernobyl accident could also be included. One of these actions was to provide for an improvement in the treatment of thyroid cancer in the populations in the affected countries.
One of the principal aids in managing thyroid cancer and treating other thyroid problems is L-Thyroxine, a replacement for the hormones naturally produced by the thyroid gland. As at May 1994 this was not produced in the Chernobyl affected regions meaning that the required supplies had to be imported.
It was estimated at the time that in Ukraine there were about 40,000 patients for whom L-Thyroxine was prescribed. The resulting overall requirement for L-Thyroxine was estimated at 55 million x 100 microgram tablets per annum. This gave rise to a significant importation cost in 1994 of about $650,000 per annum. The requirements in Belarus were about the same. Russian requirements were not considered under this project as it had been reported that a manufacturing facility was under construction in the country.
Consequently, a project was programmed under the TACIS 1993 Chernobyl regional programme for the design and installation of facilities, at the Borschahiwska Pharmaceutical Factory of the FARMAK Joint Stock Company in Ukraine, for the forming and packaging of L-Thyroxine tablets and subsequent storage and distribution of the drug for the Chernobyl affected regions.
The Terms of Reference for the project had been prepared under a previous contract (see 22782).
A conceptual design study was undertaken by Fichtner (see contract 23214). A general concept for the L-Thyroxine tablet production facility was developed and Technical Specifications were prepared for the procurement of the equipment to be financed through the TACIS programme, comprising:

• Technical equipment for the manufacturing, tableting and packaging of the L-Thyroxine tablets;
• Interior equipment, heating, ventilation and air-conditioning for the facility premises.

The equipment was purchased through a separate supply contract (see project U5.09/93).
Fichtner was contracted by the European Commission (Contract 24030) to perform the tendering and to follow-up the implementation of the above supply contracts.
The present contract was for the manufacture and supply of the equipment.

Objective
The scope of supply was the design, manufacture, delivery, installation and commissioning of equipment for an L-Thyroxine tablet production facility comprising:
1. Technical equipment for manufacturing, tableting and packaging of L-Thyroxine tablets
The required capacity of the facilities to manufacture and package the L-Thyroxine tablets was 120 Million tablets per year in one-shift operation, each tablet weighing 200 mg and containing 100 micrograms of active substance. The foreseen (maximum) batch size was 100 kg (approx. 200 litres of granules).
The production line consisted essentially of:

• 1 (one) mill for preparation of the starting materials
• 1 (one) set of 3 electronic weighing scales, with LF-unit
• 1 (one) closed bowl granulator (mixer, granulator, dryer) capacity 300- 400 litres
• 1 (one) fine calibrator for granules
• 1 (one) tumbler (end mixer)
• 1 (one) tablet press, minimum capacity 70,000 tablets per hour
• 1 (one) blister machine for aluminium/PVC blister strips, minimum capacity 7,000 blister strips per hour with 10 tablets each
• 1 (one) cartoning machine, min. capacity 1 400 (700) cartons per hour with 5 (10) blisters each
• 1 (one) bundling machine for the formation of handy bundles of 10 to 20 cartons, (minimum) capacity 70 - 140 cartons per hour
• diverse equipment for transport, handling and analysis of materials (bins, pallets, pallet trucks, etc.)

2. Interior equipment, heating, ventilation and air-conditioning
The production facilities had to be installed in an existing building of the FARMAK company, Kiev. An essential part of the scope was the optimization of the preliminary layout together with FARMAK.
The scope of supply and services consisted essentially of:

• interior equipment for reconstructing the existing building according to GMP-standard:
  • approx. 980 m2 of walls and 700 m2 of ceilings according to GMP
  • including integrated windows, doors, electrical power distribution and supply, lighting, piping works for internal supply with water, cooling water, pharmaceutical water, pressurized air, etc.
• heating, ventilation and dust extraction system for the production area.

The supplier was responsible for the complete installation of the supplied system as well as the commissioning. During the time on site, the supplier was also responsible for training the End user personnel.

Results
The supply contract was signed in August 1997.
The equipment was delivered and installed by May 1998. Start-up, personnel training and trial operation were completed by early June and provisional acceptance took place on 5 June 1998. The final acceptance certificate was signed in June 1999.